Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis

Critical Illness Clinical Trial

Official title:

: Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03243864
• Other study ID #: 866
• Status: Recruiting
• Start date: March 13, 2017
• Est. completion date: October 21, 2020

Study information

• Verified date: April 2019
• Source: Temple University
• Contact: Christina Rose, Pharm.D.
• Phone: 215-707-8057
• Email: rosecm[@]temple.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study's primary objective is to determine plasma and dialysis fluid concentrations in patients prescribed ceftazidime-avibactam as the standard treatment for their infection and requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the prescribed dose meets pharmacodynamic targets.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 21, 2020
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults > 18 years of age

• Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure

• documented or suspected infection requiring a prescription for ceftazidime-avibactam

Exclusion Criteria:

• Patients on CRRT < 24 hours

• Patients on ceftazidime-avibactam < 24 hours

• Patients unable to remain on CRRT for 32 hours continuously without clotting

Related Conditions & MeSH terms

• Bacterial Infections
• Critical Illness
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Ceftazidime-avibactam
Patients will be started on 2.5 gm IV every 8 hours

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ceftazidime plasma concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Primary	Avibactam plasma concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Primary	Ceftazidime effluent concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Primary	Avibactam effluent concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Secondary	Maximum plasma concentration (Cmax)	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Secondary	Number of participants with adverse effects as a measure of safety	Measure of safety	Days 1-30
Secondary	Minimum plasma concentration (Cmin)	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Secondary	Half-life (t1/2)	hours	8-hours
Secondary	Clearance (Cl)	L/hr	8-hours
Secondary	AUC 0 to 8 hours	mg*hr/L	8-hours
Secondary	Sieving Coefficient	SC	8-hours